• YAKHAK HOEJI
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• v.57 no.3
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• pp.173-186
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• 2013

To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea's regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.

• Journal of Food Hygiene and Safety
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• v.39 no.3
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• pp.209-220
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• 2024

Cavier is graded as Beluga, Osetra, and Sevruga based on the species of sturgeon (Acipenser sinensis). In this study, we developed an analytical method for determining the grade of black caviar using DNA barcodes and KASP markers. To identify the sturgeon species, ten black caviar samples were collected, and a reference DNA barcode library was developed using five genes (namely, 16S ribosomal RNA, cytochrome b, cytochrome c oxidase subunit I, cytochrome c oxidase subunit II, and NADH dehydrogenase subunit 5 genes). To develop the KASP markers, we selected 11 markers that could distinguish between the five grades of black caviar. As a result, specific markers for each of the targeted caviars were clustered into FAM-positive sections. DNA barcoding and the KASP assay revealed that one Beluga, six Osetra, and three Sevruga were identified among the ten caviar samples. Moreover, we found that the sturgeon species were mislabeled in two products. Here, we aimed to develop a KASP assay based on SNP that allows rapid and easy identification of caviar grade. These methods are expected to contribute to preventing the distribution of illegal products.

• The monthly packaging world
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• s.180
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• pp.95-105
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• 2008

식품의약품안전청은 기구 및 용기.포장의 규격 중 유리제, 도자기제, 법랑 및 옹기류에 대해 납,카드뮴 규격을 강화해 국제화 및 식품용기의 안전관리를 도모하고자 기구 및 용기.포장의 기준 및 규격을 개정 고시했다. 주요내용으로는 유리제, 도자기제, 법랑 및 옹기류의 납,카드뮴 규격을 강화하고 폴리아미드/나일론 중 4.4 '-메틸렌다이아닐린 용출규격을 신설했으며 납, 카드뮴 시험법을 개정했다. 본 고에서는 개정안과 함께 신.구조문을 비교해 알아보도록 한다.

• Proceedings of the Korea Information Processing Society Conference
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• 2013.11a
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• pp.445-448
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• 2013

본 논문에서는 어플리케이션을 통하여 우리가 자주 사용하는 의학품을 좀 더 안전하고 편리하게 다루어 사용자가 무분별하게 사용하는 약물 오남용을 줄이고 안전사고를 예방하는데 초점을 두었다. 또한 어플리케이션 특유의 편리함과 간편함을 통하여 사용자에게 좀 더 다가가는데 목적을 두었다.

• Food Science and Industry
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• v.50 no.2
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• pp.52-59
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• 2017

Nano-packaging is defined as food packages produced with nanoparticles or using nanotechnology in their process. Nano-packaging has become more available in the current market because of its enhanced functional properties such as antimicrobial and barrier properties. However, consumers have worried about toxicity by migration of nanomaterials from packaging to food. Currently, many commercialized products are coated or composited with inorganic nanomaterials such as nanosilver, nanoclay, zinc oxide, titanium dioxide, and so on. In this study, nanomaterials used in food packaging were classified and the commercially available nano-packaging were screened. Study on the migration of nanomaterials in various food simulants was also summarized.

• Journal of Food Hygiene and Safety
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• v.34 no.2
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• pp.158-169
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• 2019

Ergot alkaloids are mycotoxin produced by fungi of the Claviceps genus, mainly by Claviceps purpurea in EU. Recently obtained informations indicates necessity for control the ergot in imported grains. Recent occurrence data of ergot alkaloids from EU countries indicate the necessities of management and control these toxins from the imported grains like rye, wheat, oat etc. The aim of this study is to optimize the liquid chromatography-tandem mass spectrometry method for determination of ergot alkaloids (ergometrine, ergosine, ergotamine, ergocornine, ergocryptine, ergocristine and their epimers (-inines) from grain and grain-based food. The test method was optimized by extracting the sample with acetonitrile containing 2 mM ammonium carbonate, purification with Mycosep cartridge, and instrumental analysis by LC-MS/MS using Syncronis C18 column. The standard calibration curves showed linearity with correlation coefficents; $R^2$ >0.99. Mean recoveries ranged from 72.0 to 111.3% at three different fortified levels (20, 50, and $100{\mu}g/kg$). The correlation coefficient expressed as precision was within the range of 1.9-12.9%. The limit or quantifications (LOQ) ranged from 0.012 to $0.058{\mu}g/kg$. The developed analytical method met the criteria of AOAC Int. and CAC validation parameters like accuracy and sensitivity. As a result, it was confirmed that the test method developed in this study is suitable for the simultaneous analysis of six species of ergot alkaloid from grains and grain products.

• Journal of Food Hygiene and Safety
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• v.37 no.3
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• pp.136-142
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• 2022

The research aims to develop a rapid and easy analytical method for methoprene using liquid chromatography-tandem mass spectrometry (LC-MS/MS). A simple, highly sensitive, and specific analytical method for the determination of methoprene in livestock products (beef, pork, chicken, milk, eggs, and fat) was developed. Methoprene was effectively extracted with 1% acetic acid in acetonitrile and acetone (1:1), followed by the addition of anhydrous magnesium sulfate (MgSO₄) and anhydrous sodium acetate. Subsequently, the lipids in the livestock sample were extracted by freezing them at -20℃. The extracts were cleaned using MgSO₄, primary secondary amine (PSA), and octadecyl (C₁₈), which were then centrifuged to separate the supernatant. Nitrogen gas was used to evaporate the supernatant, which was then dissolved in methanol. The matrix-matched calibration curves were constructed using 8 levels (1, 2.5, 5, 10, 25, 50, 100, 150 ng/mL) and the coefficient of determination (R²) was above 0.9964. Average recoveries spiked at three levels (0.01, 0.1, and 0.5 mg/kg), and ranged from 79.5-105.1%, with relative standard deviations (RSDs) smaller than 14.2%, as required by the Codex guideline (CODEX CAC/GL 40). This study could be useful for residue safety management in livestock products.

• The Korean Chronic Disease News
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• no.312
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• pp.1-18
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• 2007

서울 마포구 보건소 하현성 소장/65세 이상 서울시민 무료 치매 검진/‘건강투자’보건의료전략 제시/국산약 해외진출,“ 현지화가 급선무”/‘의약품정책협의회’공식 출범/서방형 성장호르몬 상품화 성공/“다 함께 건강증진, 안전한 마포 건설”/지역자원역량강화 통합적 서비스 체계 구축/전립선비대증‘녹차’예방 효과 커/건강검진 수검자 비만율 30.64%/“식품첨가물, 아토피피부염과 상관없다”/허리둘레 크면 당뇨위험 2.2배 증가/발의 구조가 무너지면 인체의 구조가 무너진다/고령친화 모델지역 기본구상/

• Journal of Food Hygiene and Safety
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• v.37 no.3
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• pp.166-172
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• 2022

This study evaluated the migrant and residue tests of lead (Pb), cadmium (Cd), nickel (Ni), arsenic (As), and antimony (Sb) in 70 tumbler samples. The migration levels of hazardous metals in all the samples were within the migration limits outlined in the Korean standards and specifications for utensils, containers, and packages. Moreover, in all the tumbler samples, only Ni was detected in 0.5% citric acid solution of a food stimulant. The maximum level of Ni 0.0144 mg/L was 14.4% of the migrant specification (not more than 0.1 mg/L), which was relatively safe. The 0.5% citric acid solution was eluted at 4℃, 70℃, and 100℃ for 30 min, and only Ni was detected while testing for migration levels according to the temperature variations; all temperature conditions conformed to the standards. The level of Ni migration increased significantly with increasing migration temperature. Regarding the residue level outside the paint-coated tumbler samples, the Pb level was found to range from N.D. to 20638.1323 mg/kg. The risk of Ni was further estimated to be at a safe level of 0.00 to 0.01% compared to the %TDI as a result.

• KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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• v.24 no.3
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• pp.107-112
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• 2018

The purpose of this study was to investigate the migration levels of lead (Pb), cadmium (Cd) and arsenic (As) from polycarbonate food contact materials into food simulant at different temperatures ($70^{\circ}C$ and $100^{\circ}C$). The method was validated by linearity of calibration curves, limit of detection (LOD), limit of quantification (LOQ), recovery, precision and uncertainty. All of 200 samples, including bottles, cups, containers, ladles, spoons and tongs were purchased from domestic markets and analyzed by inductively coupled plasma mass spectrometry (ICP-MS). Mean concentrations of positive samples were higher at $100^{\circ}C$ than $70^{\circ}C$ as showing a dependency of migration temperature. The migration concentrations ranged from not-detected (ND) to $4.67{\mu}g/L$, ND to $0.49{\mu}g/L$L and ND to $2.91{\mu}g/L$ for Pb, Cd and As, respectively, which were far below the migration limits of Korea standards and specifications for food utensils, containers and packages.